BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    MDR report key: 4251889 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40693
    Event Type
    Death
    Date Received
    November 14, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: CMPLNT-(B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER MINICAP. THIS REPORT INVOLVES A PATIENT WHO EXPERIENCED AN INFECTION AND FEVER IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO PERITONITIS REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT AS A CAUSE FOR THE REPORTED SYMPTOMS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS CMPLNT-(B)(4), CMPLNT-(B)(4), AND CMPLNT-(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN UNSPECIFIED INFECTION, MANIFESTED BY FEVER, AND SUBSEQUENTLY PASSED AWAY DUE TO THE INFECTION COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. EIGHTEEN DAYS PRIOR TO DEATH, THE PATIENT WAS HOSPITALIZED FOR THE FEVER. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNKNOWN MEDICINE FOR THE FEVER. SUBSEQUENTLY THE PATIENT PASSED AWAY AND THE CAUSE OF DEATH WAS REPORTED TO BE DUE TO INFECTION. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED, IF DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736708 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL PD-2, 1.5% AMBUFLEX, HOMECHOICE| TRANSFER SET, CASSETTE, TITANIUM ADAPTER